4 CLINICAL PARTICULARS4.1 Therapeutic indications
As a supplement for the prevention of vitamin deficiency states. As an aid to the maintenance of normal health and growth in infants and young children.

4.2 Posology and method of administration Method of administration Dose: Infants from 6 weeks to one year : 0.3 ml daily (7 drops).
Older children, adults and elderly: 0.6 ml daily (14 drops) or as directed by the physician.

4.3 Contraindications Hypersensitivity to any of the active substances or any of the excipients.
Contra-indicated in hypercalcaemia.
Contra-indicated in women who are (or may become) pregnant (see 4.6).

4.4 Special warnings and precautions for use When multivitamin preparations are prescribed allowance must be made for vitamins from other sources. No other preparations contain vitamin A should be taken with this preparation except under medical supervision.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Label will state:
• Do not exceed the stated dose.
• Keep out of the Reach and Sight of children.
• Contains sodium methylhydroxybenzoate (E219). May cause allergic reactions (possibly delayed).
• Contains sucrose: If you have been told by doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

4.5 Interaction with other medicinal products and other forms of interaction Vitamin A:
Neomycin: Absorption of vitamin A possibly reduced by neomycin.
Retinoids: Risk of hypervitaminosis A when vitamin A given with retinoids.
Vitamin D: Barbiturates, carbamazepine, phenytoin, primidone: Vitamin D requirements possibly increased when given with either of the listed medications.

Diuretics thiazide: Increased risk of hypercalacaemia when vitamin D given with thiazide and related diuretics.

4.6 Fertility, pregnancy and lactationIn view of evidence suggesting that high levels of vitamin A may cause birth defects, women who are (or may become) pregnant are advised not to take vitamin A supplements (including tablets and fish-liver oil drops), except on the advice of a doctor or an antenatal clinic (see section 4.3).

Vitamin D is secreted in breast milk and may cause hypercalcaemia in infants.

4.7 Effects on ability to drive and use machines None known.

4.8 Undesirable effects No undesirable effects due to the administration of Dalivit Drops have been reported, and none can be expected if the dosage schedule is adhered to.

Excessive dose of vitamins A and D can lead to hypervitaminosis.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

6.6 Special precautions for disposal This medicine must not be used after the date (Exp) printed on the back.
Any unused product or waste material should be disposed of in accordance with local requirements.